A Randomized Controlled Trial Of Severe Functional Constipation Treated By Deep Needling In Tianshu And Fujie

Purpose:By a randomized controlled trial, to objectively evaluate the short-term efficacy, long-term efficacy, safety of deep needling and changes in the quality of life of severe functional constipation, which are treated by deep needling in Tianshu and Fujie, combined with electro-acupuncture, so as to provide clinical evidence for acupuncture treatments of severe functional constipation.Methods:70cases of severe FC conforming to the criteria of this subject were randomly divided into test group(Electro-acupuncture group, EA) and the control group (sham electro-acupuncture group, Sham EA), having35cases in each group. To observe changes in CSBM, effective rate, SBM and the PAC-QOL scale of patients in two groups before and after treatment. To observe the safety of deep needling.Results:63patients were randomly divided into (33patients) and control group (30patients).1.CSBM comparison. Compared with before treatment, each point of the test group has statistical significance (P<0.01), the control group has no significant difference (P>0.05)except treatment in8weeks has statistical significance (P<0.05). Comparison between groups at different time points were significantly different (P<0.01).Conclusion:Patients in the test group better increased in CSBM than those in the control group.2. Effective rate comparison. Comparison between groups at the end of treatment period and follow-up period were significantly different (P<0.01). Conclusion:Patients in the test group have higher effective rate than those in the control group.3.SBM comparison. Compared with before treatment, each point of the two groups has statistical significance (P<0.01), Comparison between groups at different time points were significantly different (P<0.01). Conclusion:Patients in the test group better increased in SBM than those in the control group.4. The PAC-QOL scale comparison. Compared with before treatment, each point of the test group has statistical significance (P<0.01) in four dimensions. Compared with before treatment, each point of the control group has statistical significance (P<0.01) in four dimensions except psychosocial discomfort(P>0.05). Comparison between groups at different time points were significantly different (P<0.05). Conclusion:The two groups have improved physical discomfort, fear and anxiety, satisfaction in patients, while the test group is better than the control group.The test group improved significantly in psychosocial discomfort,while the control group has no obvious improvement in it.5.Safety of EA comparison. Comparison between groups in acupuncture pain and EA acceptance are significantly different (P<0.01). Before and after treatment,63patients take a stool occult blood test,both were negative. During the study none of the clinical adverse events appear. Conclusion:Deep needling is relatively safe.Conclusion:Deep needling with EA in Tianshu and Fujie, again with Shangjuxu point, to treat severe FC patients, have obvious short-term efficacy and long-term efficacy, within safety and improvement of the quality of life.